Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbetocin 100 µg | Experimental | Carbetocin injection, 100µg, single injection |
|
| oxytocin 5 u | Active Comparator | Oxytocin 5U, injection, single injection |
|
| placebo (NaCl) | Placebo Comparator | Saline single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbetocin 100 µg | Drug | Hemodynamic effect of |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output | The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery. | 2.5 minutes |
| Arterial Blood Pressure | The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery. | 2.5 min |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | The calculated estimated blood loss from delivery until 2 h after intervention | 120 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leiv Arne Rosseland, MD PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet | Oslo | 0027 | Norway | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23598289 | Result | Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesaeter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd. | |
| 34127491 | Derived | Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Carbetocin 100 µg | carbetocin 100 µg : Hemodynamic effect of |
| FG001 | Oxytocin 5 u | oxytocin 5 u : Hemodynamic effect of |
| FG002 | Placebo (NaCl) | placebo (NaCl) : Hemodynamic effect of |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Carbetocin 100 µg | carbetocin 100 µg : Hemodynamic effect of |
| BG001 | Oxytocin 5 u | oxytocin 5 u : Hemodynamic effect of |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiac Output | The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery. | Posted | Mean | 95% Confidence Interval | percentage change in cardiac output | 2.5 minutes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carbetocin 100 µg | carbetocin 100 µg : Hemodynamic effect of |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling of warmth | Skin and subcutaneous tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Leiv Arne Rosseland | Oslo University Hospital | +4723070000 | lrossela@ous-hf.no |
Not provided
| ID | Term |
|---|---|
| C020731 | carbetocin |
| D007267 | Injections |
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D010909 | Pituitary Hormones, Posterior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| oxytocin 5 u | Drug | Hemodynamic effect of |
|
|
| placebo (NaCl) | Drug | Hemodynamic effect of |
|
|
| Division of Anesthesia and Intensive Care Medicine |
| Oslo |
| 0027 |
| Norway |
| BG002 | Placebo (NaCl) | placebo (NaCl) : Hemodynamic effect of |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Arterial Blood Pressure | The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery. | Posted | Mean | 95% Confidence Interval | percentage change in arterial blood pres | 2.5 min |
|
|
|
| Secondary | Bleeding | The calculated estimated blood loss from delivery until 2 h after intervention | Posted | Mean | Standard Deviation | ml blood loss | 120 minutes |
|
|
|
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | Oxytocin 5 u | oxytocin 5 u : Hemodynamic effect of | 0 | 26 | 9 | 26 |
| EG002 | Placebo (NaCl) | placebo (NaCl) : Hemodynamic effect of | 0 | 25 | 2 | 25 |
| Chest pain | Cardiac disorders |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders |
|
| Palpitations | Cardiac disorders |
|
| Flushing | Skin and subcutaneous tissue disorders |
|
| Headache | Nervous system disorders |
|
| Nasal congestion | Skin and subcutaneous tissue disorders |
|
| Xerostomia | Gastrointestinal disorders |
|
| Metallic taste | Nervous system disorders |
|
Not provided
Not provided
Not provided
| D010907 |
| Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |